Cortech has filed an Investigational New Drug application with the US Food and Drug Administration to begin trials with its lead antigen-specific immunomodulator, Sulfasim, for the prevention of sulfamethoxazole allergy in HIV-infected patients.
The company says that a sulfamethoxazole and trimethoprim combination is the drug of choice for the treatment or prevention of Pneumocystis carinii pneumonia, the most frequent opportunistic infection in AIDS patients. Unfortunately, it adds, as many as 60% of patients receiving the combination experience adverse reactions to the sulfamethoxazole component of the combination.
The adverse reactions are believed to be due to antisulfamethoxazole antibodies that are formed in response to the drug. In preclinical studies, Sulfasim blocked immune system recognition of the drug so that no antibodies were generated. The Phase I/II trials be will carried out under the auspices of the US National Institute of Allergy and Infectious Diseases.
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